Senior Quality Systems Engineer

Access Vascular designs manufactures and distributes sterile catheter-based software-enabled and electromechanical medical devices. This role helps oversee our Quality Management System and provides Quality Engineering support across Operations working closely with a small hands-on team under AVIs QMS and FDA QMSR requirements.

We know this list is extensive. It reflects the range of work on our teams plate not a checklist every candidate needs to fully satisfy. If you have strong experience in some of these areas and are excited to grow into the rest we want to hear from you.

Quality Management System

• Help maintain and continuously improve our QMSR and ISO 13485-compliant QMS
• Support improvements to SOPs work instructions forms test protocols and other controlled documents
• Support document control and records management under 21 CFR Part 820
• Participate in internal audits and support external audits (FDA supplier)
• Lead or support CAPA investigations root cause analysis timely closure effectiveness verification
• Help develop quality metrics and data analysis to guide risk-based decisions

Operations & Supplier Quality

• Partner with Operations to help ensure manufacturing processes are controlled and validated
• Contribute to risk management sterilization validation and data integrity practices
• Support incoming inspection nonconforming material control and disposition
• Provide Quality Engineering input on infrastructure and expansion projects
• Support supplier qualification evaluation and monitoring
• Help conduct supplier audits and review corrective action responses

Post-Market Surveillance

• Support complaint handling MDR reporting and trend analysis
• Stay current on relevant standards and regulations and help keep the team informed
• Assist with preparation for FDA inspections and Notified Body audits

Leadership & Culture

• Help champion a proactive quality culture across a small multidisciplinary team
• Offer quality training and mentoring where you can we all wear a few hats here!

Qualifications

• Bachelors degree in Engineering Life Sciences or a related technical field
• Minimum of 5 years of quality systems experience with a medical device manufacturing company
• Proven track record with implementing evolving and improving medical device company quality management systems (QMS) compliant to FDA 21 CFR Part 820 ISO 13485:2016 and ISO 14971
• Demonstrated experience owning a QMS end-to-end including CAPA document control complaints internal auditing and supplier quality
• Strong technical writing skills with the ability to produce clear compliant documentation
• Experience with statistical techniques sampling plans and data analysis for validation and process capability

Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .